AdviewII™ 9005SP

GUDID 00634782084721

Adview2 SpO2 Finger Sensor,Reusable, Adult, 8’ cable

AMERICAN DIAGNOSTIC CORP

Pulse oximeter probe, reusable Pulse oximeter probe, reusable Pulse oximeter probe, reusable Pulse oximeter probe, reusable Pulse oximeter probe, reusable Pulse oximeter probe, reusable Pulse oximeter probe, reusable Pulse oximeter probe, reusable Pulse oximeter probe, reusable Pulse oximeter probe, reusable Pulse oximeter probe, reusable Pulse oximeter probe, reusable Pulse oximeter probe, reusable Pulse oximeter probe, reusable Pulse oximeter probe, reusable Pulse oximeter probe, reusable Pulse oximeter probe, reusable

• Primary Device ID: 00634782084721
• NIH Device Record Key: 881cfce6-7b0d-4b56-b2c0-53be94053a76
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AdviewII™
• Version Model Number: 9005SP
• Catalog Number: 9005SP
• Company DUNS: 108999095
• Company Name: AMERICAN DIAGNOSTIC CORP
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: true

Customer Support Contacts

• Phone: 1-800-232-2670
• Email: info@adctoday.com
• Phone: 1-800-232-2670
• Email: info@adctoday.com
• Phone: 1-800-232-2670
• Email: info@adctoday.com
• Phone: 1-800-232-2670
• Email: info@adctoday.com
• Phone: 1-800-232-2670
• Email: info@adctoday.com
• Phone: 1-800-232-2670
• Email: info@adctoday.com
• Phone: 1-800-232-2670
• Email: info@adctoday.com
• Phone: 1-800-232-2670
• Email: info@adctoday.com
• Phone: 1-800-232-2670
• Email: info@adctoday.com
• Phone: 1-800-232-2670
• Email: info@adctoday.com
• Phone: 1-800-232-2670
• Email: info@adctoday.com
• Phone: 1-800-232-2670
• Email: info@adctoday.com
• Phone: 1-800-232-2670
• Email: info@adctoday.com
• Phone: 1-800-232-2670
• Email: info@adctoday.com
• Phone: 1-800-232-2670
• Email: info@adctoday.com
• Phone: 1-800-232-2670
• Email: info@adctoday.com
• Phone: 1-800-232-2670
• Email: info@adctoday.com

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Operating and Storage Conditions

• Handling Environment Temperature: Between 41 Degrees Fahrenheit and 113 Degrees Fahrenheit
• Handling Environment Temperature: Between 41 Degrees Fahrenheit and 113 Degrees Fahrenheit
• Handling Environment Temperature: Between 41 Degrees Fahrenheit and 113 Degrees Fahrenheit
• Handling Environment Temperature: Between 41 Degrees Fahrenheit and 113 Degrees Fahrenheit
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 41 Degrees Fahrenheit and 113 Degrees Fahrenheit
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 41 Degrees Fahrenheit and 113 Degrees Fahrenheit
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 41 Degrees Fahrenheit and 113 Degrees Fahrenheit
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 41 Degrees Fahrenheit and 113 Degrees Fahrenheit
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 41 Degrees Fahrenheit and 113 Degrees Fahrenheit
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 41 Degrees Fahrenheit and 113 Degrees Fahrenheit
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 41 Degrees Fahrenheit and 113 Degrees Fahrenheit
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 41 Degrees Fahrenheit and 113 Degrees Fahrenheit
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 41 Degrees Fahrenheit and 113 Degrees Fahrenheit
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 41 Degrees Fahrenheit and 113 Degrees Fahrenheit
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 41 Degrees Fahrenheit and 113 Degrees Fahrenheit
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 41 Degrees Fahrenheit and 113 Degrees Fahrenheit
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 41 Degrees Fahrenheit and 113 Degrees Fahrenheit
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 41 Degrees Fahrenheit and 113 Degrees Fahrenheit
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 41 Degrees Fahrenheit and 113 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00634782084721 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K082846

FDA Product Code

• DQA: Oximeter

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2018-08-10
• Device Publish Date: 2016-09-23

On-Brand Devices [AdviewII™]

• 00634782094911: Adview2 SpO2 Finger Sensor,Reusable, Adult, 8’ cable Canada
• 00634782094898: Adview2 SpO2 Module,ChipOx Canada
• 00634782094461: Adview2 Diagnostic Station,BP only Canada
• 00634782085605: Adview2 Diagnostic Station,BP/SpO2 Masimo Set/Temp Modules
• 00634782085599: Adview2 Diagnostic Station,BP/SpO2Masimo Set Modules
• 00634782085568: Adview2 Temp Kit,Rectal, Red
• 00634782085551: Adview2 Temp Kit,Oral/Axillary, Blue
• 00634782085544: Adview2 Thermometer Module,Rectal, Red
• 00634782085537: Adview2 SpO2 Multisite Sensor,10 Adult, 10 Ped wraps
• 00634782085520: Adview2 SpO2 Module,Masimo Set
• 00634782085513: Adview2 Pediatric Cuff Kit,
• 00634782085506: Adview2 Adult Cuff Kit,
• 00634782085490: Adview2 Five Cuff Kit,
• 00634782085452: Shelf for Adview2 Printer,on Mobile Stand
• 00634782085438: Adview2 USB Cable,6’, USB to mini-USB
• 00634782085421: Adview2 Calibration Plug,for Temp Module
• 00634782085407: Adview2 Cuff, 1 Tube,Child, Green, w/Male Bayonet
• 00634782085391: Adview2 Cuff, 1 Tube,Thigh, Brown, w/Male Bayonet
• 00634782085384: Adview2 Cuff, 1 Tube,LgAdult Plus,Burgundy,wBayonet
• 00634782085377: Adview2 Cuff, 1 Tube,Lg Adult, Burgundy, w/MBayonet
• 00634782085360: Adview2 Cuff, 1 Tube,Adult Plus, Navy, w/M Bayonet
• 00634782085353: Adview2 Cuff, 1 Tube,Adult, Navy, w/Male Bayonet
• 00634782085346: Adview2 Cuff, 1 Tube,SmAdult, RoyBlu, Male Bayonet
• 00634782084820: Adview2 Barcode Scanner,w/Holster
• 00634782084813: Paper for Adview2 Printer,Tray of 10 rolls
• 00634782084806: Adview2 Printer ,w/Paper
• 00634782084790: Adview2 Wi-Fi Dongle,AC Dual Band USB Adapter
• 00634782084783: Adview2 Wall Mount Bracket w/Basket,
• 00634782084776: Adview2 Mobile Stand
• 00634782084769: Adview2 Desktop Storage Caddy
• 00634782084752: Adview2 Thermometer Well,Rectal, Red
• 00634782084745: Adview2 Thermometer Well,Oral/Axillary, Blue
• 00634782084738: Adview2 Thermometer Module,Oral/Axillary, Blue
• 00634782084721: Adview2 SpO2 Finger Sensor,Reusable, Adult, 8’ cable
• 00634782084714: Adview2 SpO2 Module,ChipOx
• 00634782084707: Adview2 BP Cable, 10’,Single Lumen, Bayonet-Bayonet
• 00634782084691: Adview2 Power Cord, USA,120VAC
• 00634782084684: Adview2 Battery, Lithium-ion
• 00634782084677: Adview2 Diagnostic Station,BP/Temp Modules
• 00634782084660: Adview2 Diagnostic Station,BP/SpO2/Temp Modules
• 00634782084653: Adview2 Diagnostic Station,BP/SpO2 Modules
• 00634782084646: Adview2 Diagnostic Station,BP only
• 00634782094942: Adview2 2D Barcode Scanner
• 00634782094935: Adview2 Linear Barcode Scanner